Follow Invezz on Telegram , Twitter , and Google News for instant updates >Alnylam Pharmaceuticals Inc (NASDAQ: ALNY) opened more than 30% up on Monday after reporting promising results from a late-stage trial of its heart drug. Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.Shares of the biopharmaceutical company are now trading at a year-to-date high of $220.  Why is it significant for Alnylam Pharmaceuticals stock?Copy link to sectionVutrisiran de ...

Company Overview - Alnylam Pharmaceuticals (ALNY) shares increased by 5.3% to $165.70, with a notable trading volume, reflecting a 5.4% gain over the past four weeks [1][2] - The rise in stock price is attributed to investor optimism regarding Amvuttra's (vutrisiran) revenue potential, which recorded sales of $195 million in Q1 2024, a 92% increase [2] Financial Performance - Alnylam is expected to report a quarterly loss of $0.78 per share, representing a year-over-year change of +64.7%, with revenues projected at $450.23 million, up 41.3% from the previous year [3] - The consensus EPS estimate has been revised slightly higher in the last 30 days, indicating a positive trend that may lead to stock price appreciation [3] Industry Context - Alnylam operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Acadia Pharmaceuticals (ACAD), whose stock rose by 3.7% to $15.30 [4] - Acadia's consensus EPS estimate has decreased by 2.8% over the past month, but shows a significant year-over-year change of +1500% [4]

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Financial Data and Key Metrics Changes - In Q1 2024, Alnylam Pharmaceuticals reported total product revenues of $365 million, reflecting a 32% year-over-year growth compared to Q1 2023 [7][26] - The gross margin on product sales was 85%, consistent with Q1 2023, but expected to decrease for the remainder of 2024 due to higher royalties on AMVUTTRA [27][28] - Non-GAAP R&D expenses increased by 13% year-over-year, driven by investments in zilebesiran and the HELIOS-B trial [27] - Non-GAAP SG&A expenses rose by 15% year-over-year, indicating operating leverage as product sales grew by 32% [27] Business Line Data and Key Metrics Changes - The TTR franchise achieved $264 million in global net product revenues, representing a 29% growth year-over-year [11][12] - The rare franchise delivered $101 million in combined global net product revenue, marking a 40% increase compared to Q1 2023 [16][17] - AMVUTTRA's U.S. sales increased by 35% year-over-year, driven by strong patient uptake [11][12] Market Data and Key Metrics Changes - The U.S. TTR sales saw a 39% increase in total demand compared to Q1 2023, despite a decrease in patients switching from ONPATTRO to AMVUTTRA [12][14] - International TTR franchise growth increased by 23% year-over-year, primarily due to AMVUTTRA demand in newly launched markets [13][14] Company Strategy and Development Direction - Alnylam aims to position itself as a leader in treating cardiovascular disease through its zilebesiran hypertension program, which has shown positive results in clinical trials [8][21] - The company is focused on advancing its pipeline with plans to file proprietary INDs for nine programs by the end of 2025, aiming to double its clinical pipeline [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a strong start to 2024, with expectations for continued revenue growth and successful outcomes from ongoing clinical trials [7][9] - The company remains optimistic about the HELIOS-B Phase 3 study results, which are expected to support a supplemental NDA filing by the end of 2024 if positive [9][20] Other Important Information - Alnylam ended Q1 2024 with cash, cash equivalents, and marketable securities of $2.4 billion, indicating a stable financial position [28] - The company reiterated its 2024 guidance for combined net product revenues between $1.4 billion and $1.5 billion, reflecting a growth rate of 13% to 21% [29] Q&A Session Summary Question: What is the relevant improvement over the control arm for HELIOS-B? - Management emphasized that delivering outcomes in the HELIOS-B study is crucial and that they are focused on demonstrating clinical significance in terms of mortality and hospitalization [34][36] Question: What would be the organizational changes if HELIOS-B succeeds or fails? - If HELIOS-B succeeds, no changes to spending guidance are anticipated. However, if it fails, prioritization across the business would be necessary [40][41] Question: How important is the ratio between hospitalization events and deaths in HELIOS-B? - Management indicated that both hospitalization and mortality events are clinically meaningful and should trend in the same direction [70][72] Question: What proportion of patients are mixed phenotype in ATTR? - It was noted that a significant proportion of patients with wild type ATTR may have concomitant polyneuropathy, highlighting the complexity of the disease [75][76] Question: Will subgroup information be shared in the top line release for HELIOS-B? - Management confirmed that they plan to provide information on primary and secondary endpoints, including subgroup analyses, during the top line results presentation [61][80]

Financial Performance - Alnylam's combined net product revenue reached $365 million, a 32% year-over-year growth compared to Q1 2023[10] - The company's total revenue increased by 55% year-over-year, reaching $494 million in Q1 2024[37] - Alnylam is reiterating its full-year 2024 net product revenue guidance of $1400 million to $1500 million, representing a 13% to 21% growth compared to 2023[38] - Non-GAAP operating profit was $2 million, a significant improvement compared to a $110 million loss in Q1 2023[37] - Cash and investments totaled $2371 million as of March 31, 2024[37] Commercial Highlights - AMVUTTRA is a clear market leader in the treatment of hATTR-PN, with over 95% of patients complying with the dosing regimen[14] - U S TTR franchise YoY growth was +35%, driven by demand for AMVUTTRA[13] - OXLUMO YoY growth of +77% driven by strong demand[18] Pipeline Development - Topline results from the HELIOS-B Phase 3 clinical study of Vutrisiran in ATTR amyloidosis patients with cardiomyopathy are expected in late June/early July 2024[21] - Zilebesiran continues to demonstrate the potential to transform the treatment of hypertension[24] - Alnylam plans to file 3 new INDs (Investigational New Drug applications)[40]

Alnylam Pharmaceuticals (ALNY) reported $494.33 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 54.8%. EPS of -$0.16 for the same period compares to -$1.40 a year ago.The reported revenue represents a surprise of +17.39% over the Zacks Consensus Estimate of $421.1 million. With the consensus EPS estimate being -$0.75, the EPS surprise was +78.67%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they com ...

Alnylam Pharmaceuticals (ALNY) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.75. This compares to loss of $1.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 78.67%. A quarter ago, it was expected that this RNA interference drug developer would post a loss of $1.20 per share when it actually produced a loss of $1.10, delivering a surprise of 8.33%.Over the last four qua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 ...

Analysts on Wall Street project that Alnylam Pharmaceuticals (ALNY) will announce quarterly loss of $0.75 per share in its forthcoming report, representing an increase of 46.4% year over year. Revenues are projected to reach $421.1 million, increasing 31.9% from the same quarter last year.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted upward by 0.6% to its current level. This demonstrates the covering analysts' collective reassessment of their initial projections during ...